Unique ID issued by UMIN | C000000035 |
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Receipt number | R000000062 |
Scientific Title | A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer |
Date of disclosure of the study information | 2005/09/04 |
Last modified on | 2005/09/04 22:37:28 |
A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
A Randomized Phase III trial of chemotherapy alone versus chemotherapy followed by gefitinib in stage IIIB/IV non-small cell lung cancer
Japan |
Stage IIIB/IV Non-small cell lung cancer
Hematology and clinical oncology |
Others
NO
A randomized phase III trial of platinum-based chemotherapy alone versus platinum-based chemotherapy followed by maintenance therapy with gefitinib in patients with stage IIIB/IV NSCLC.
Pharmacokinetics
Exploratory
Overall survival
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Platinum doublet chemotherapy more than 3 cycles up to 6 cycles.
Platinum doublet chemotherapy 3 cycles followed by gefitinib except PD cases.
20 | years-old | <= |
75 | years-old | > |
Male and Female
Histologically or cytologically confirmed NSCLC
Stage IIIB/IV
No prior treatment
Measurable disease
ECOG PS 0-1
Adequate organ function
Age 20-74
Written informed consent
Pregnancy or breast feeding
Past history of drug hypersensitivity
SVC syndrome
Pleural or pericardial effusion that required drainage
Active infection
Interstitial pneumonia or active lung fibrosis
Symptomatic brain metastasis
Active concomitant malignancy
Uncontrolled diabetes
Uncontrolled heart disease
600
1st name | |
Middle name | |
Last name | Toyoaki Hida |
Aichi cancer center hospital
Department of Thoracic Oncology
1-1 Kanokoden, Chikusa-ku, Nagoya
1st name | |
Middle name | |
Last name |
West Japan Thoracic Oncology Group (WJTOG)
West Japan Thoracic Oncology Group (WJTOG)
West Japan Thoracic Oncology Group (WJTOG)
West Japan Thoracic Oncology Group (WJTOG)
Non profit foundation
NO
2005 | Year | 09 | Month | 04 | Day |
Unpublished
No longer recruiting
2003 | Year | 01 | Month | 20 | Day |
2004 | Year | 04 | Month | 01 | Day |
2007 | Year | 05 | Month | 01 | Day |
2005 | Year | 08 | Month | 02 | Day |
2005 | Year | 09 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000062
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